Bile Leakage From Biliary Anastomosis, Bile Stricture, Liver Transplantation, Liver Transplant; Complications
Conditions
Brief summary
This study was designed to demonstrate incidence of biliary complication rates after living donor liver transplantation according to the implantation of external biliary drainage throug duct-to-duct anastomosis site.
Detailed description
Biliary complication is the most common complications after liver transplantation, and it happens more often after living donor liver transplantation (LDLT) than deceased donor liver transplantation. Many transplant centers adopted their own methods to improve biliary complications after LDLT. One suggested method is the application of external biliary drainage (EBD). A prospective study was planned to demonstrate effect of EBD on biliary complication after LDLT. Patients who underwent LDLT with duct-to-duct anastomosis will be randomly assinged to application of EBD or conventional duct-to-duct anastomosis without EBD according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two groups. Primary outcome is biliary complication incidence 1 year after LDLT.
Interventions
PROCEDUREExternal biliary drainage
Application of external biliary drainage through duct-to-duct anastomosis
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Living donor liver transplantation * Adult patient (\>=18 years old) * Patients who are available for at least 3 year follow-up after LDLT
Exclusion criteria
* Patients requring hepaticojejunostomy due to anatomical factor or underlying disease * Re-transplantation * Multiorgan transplantation * Emergency transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of biliary complication within 1 year after LDLT | 1 year | Biliary stricture/leakage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of biliary complication within 3 year after LDLT | 3 year | Biliary stricture/leakage |
| Complication associated with external biliary drainage | 3 year | Dislocation, retraction, reposition, leakage through tube site, hemorrhage |
| Graft survival | 3 year | Survival of liver graft |
| Patient survival | 3 year | Patient survival after LDLT |
| Patient-reported outcome | 3 year | Questionnaire survey |
Countries
South Korea
Contacts
Primary ContactSu young Hong, MD
Outcome results
None listed